Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06617312

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity

Led by University of California, Los Angeles · Updated on 2025-12-03

64

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will randomize 64 non-treatment seeking individuals who smoke cigarettes daily in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity.

CONDITIONS

Official Title

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between the ages of 18 and 65 and provide informed consent
  • Smoke 5 or more combustible cigarettes per day
  • Not seeking treatment for smoking
Not Eligible

You will not qualify if you...

  • Current use of other smoking cessation aids (bupropion, varenicline, nortriptyline, nicotine replacement therapy)
  • More than 3 months of smoking abstinence in the past year
  • Use of non-cigarette tobacco products or electronic cigarettes more than 5 times in the 28 days before enrollment
  • Current use of psychoactive drugs (excluding cannabis), detected by urine test
  • Diagnosis in the past 12 months of substance use disorder except tobacco, mild cannabis, or mild-to-moderate alcohol use disorders
  • History of psychotic disorders, bipolar disorder, or major depression with suicidal ideation
  • Current suicidal thoughts or history of suicide attempt
  • Serious medical illness in the past 3 months, including recent heart attack, unstable angina, stroke, cerebrovascular event, or heart failure hospitalization
  • Medical conditions that may interfere with safe participation
  • Kidney impairment with creatinine clearance over 60 mL/min
  • Lab abnormalities exceeding Grade 2 per FDA guidance
  • Uncontrolled high blood pressure (≥160/100 mmHg)
  • Abnormal electrocardiogram
  • Non-removable metal objects in the body
  • Claustrophobia
  • Serious head injury or unconsciousness over 30 minutes
  • Weight over 250 pounds
  • Pregnancy, nursing, or planning pregnancy during the study; females must agree to effective birth control methods unless sterile
  • Previous adverse reactions to varenicline
  • Intense fear of needles or adverse reaction to needle puncture

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of California Los Angeles

Los Angeles, California, United States, 90049

Actively Recruiting

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Research Team

D

Dylan E Kirsch, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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